CTBS Regulatory Standards 2

Question 1

Under 21 CFR Part 1271, which category of HCT/Ps is subject to the least regulatory oversight?

Accepted Answer

361 HCT/Ps meeting all criteria for minimal manipulation and homologous use

Answer

361 HCT/Ps that meet criteria for minimal manipulation, homologous use, no systemic effect, and no combination with drugs/devices are regulated solely under Section 361 of the PHS Act.

Question 2

What is the primary purpose of the AATB's Accreditation Program?

Accepted Answer

To ensure tissue banks meet established standards for safety, quality, and efficacy

Answer

AATB accreditation verifies that a tissue bank operates in accordance with AATB Standards, promoting safety and quality in tissue banking.

Question 3

How frequently must FDA-registered tissue establishments update their registration information if there are no changes?

Accepted Answer

Annually

Answer

Under 21 CFR Part 1271, tissue establishments must renew their registration with FDA annually, even if no information has changed.

Question 4

Which document must accompany a tissue allograft to ensure traceability from donor to recipient?

Accepted Answer

Labeling that enables tracking from donor to consignee and consignee to donor

Answer

21 CFR 1271.290 requires labeling that enables tracking from donor to consignee and from consignee to donor to maintain complete traceability.

Question 5

Under AATB Standards, what must be documented in a tissue bank's Standard Operating Procedures (SOPs)?

Accepted Answer

All activities that affect the safety, quality, and efficacy of tissue

Answer

AATB Standards require SOPs to cover all activities that could affect tissue safety, quality, and efficacy, ensuring comprehensive procedural documentation.

(CTBS) Certified Tissue Bank Specialist Practice Test

(CTBS) Certified Tissue Bank Specialist Practice Test

CTBS Regulatory Standards 2